NCT00234546

Brief Summary

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

First QC Date

October 6, 2005

Last Update Submit

July 25, 2019

Conditions

Muscle SpasticityCerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

  • Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position

    week 4

Secondary Outcomes (3)

  • Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale)

    weeks 4, 8, 12 & 24

  • Voluntary and passive joint range of motion goniometer assessment

    weeks 4, 8, 12 & 24

  • Pain Assessment using visual analogue scale for pain

    weeks 4, 8, 12 & 24

Study Arms (2)

1

EXPERIMENTAL

Dysport

Biological: Botulinum toxin type A

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Botulinum toxin type ABIOLOGICAL

1 injection, 500 U at day 0. The study will last for 6 months in each patient.

Also known as: AbobotulinumtoxinA (Dysport®)
1
PlaceboDRUG

1 injection at day 0. The study will last for 6 months in each patient.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke)
  • CT/MRI scan required to classify ischaemic / haemorrhagic stroke
  • Patient recruited 2-12 weeks after stroke
  • Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint

You may not qualify if:

  • The patient has bleeding disturbances or having used coumarin derivatives
  • The patient is currently receiving drugs affecting neuromuscular transmission
  • Co-existing severe systemic illness which may adversely affect the functional outcome
  • Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Prince of Wales Hospital

Shatin, Hong Kong

Location

University Hospital of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

University of Santo Tomas

Manila, 3001 MAB, Philippines

Location

TTSH Rehabilitation Centre

Singapore, 569766, Singapore

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VC, Delgado-De Los Santos MM, Chua KS, Abdullah SJ, Zakine B, Maisonobe P, Magis A, Wong KS. Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2012 Sep;26(7):812-21. doi: 10.1177/1545968311430824. Epub 2012 Feb 27.

    PMID: 22371239RESULT

MeSH Terms

Conditions

Muscle SpasticityStroke

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 7, 2005

Study Start

February 1, 2003

Study Completion

October 1, 2007

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

SG(1)PH(1)HK(1)MY(1)TH(1)